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U.S. Department of Health and Human Services

Class 2 Device Recall Stellant CT Dual Syringe Kits

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 Class 2 Recall
Stellant CT Dual Syringe Kits
see related information
Date Posted July 09, 2010
Recall Status1 Terminated on October 13, 2010
Recall Number Z-1954-2010
Recall Event ID 55894
Premarket Notification
510(K) Number
K023183 
Product Classification Injector And Syringe, Angiographic - Product Code DXT
Product Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK
Code Information 99725, 99726, 99727, 99728, 99729, 99730, 99731, 99733, 99734, 99747, 99748, 99749, 99750, 99753, 99754, 99755, 99757, 99766, 99767, 99768, 99772, 99775, 99776, 99777, 99778, 99813, 100053, 100464, 100465, 100466, 100467, 100471, 100472, 100473, 100474, 100475, 100476, 100477, 100478, 100479, 100488, 100512, 100513, 100514, 100515, 100516, 100517, 100518, 100519, 100520, 100521, 100523, 100524, 100525, 100526, 100528, 100529, 100531, 100532, 100533, 100535, 100537, 100538, 100539, 100541, 100542, 100543, 100546, 100547, 100549, 100550, 100551, 100552, 100553, 100555, 100558, 100559, 100560, 100561, 100564, 100567, 100568, 100569, 100570, 100897, 101378, 101379, 101380, 101386, 101387, 101391, 101394 with exp dates between 2/2014 to 4/2014.
Recalling Firm/
Manufacturer
Medrad Inc
100 Global View Dr
Warrendale, Pennsylvania 15086
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Kits contain a T connector that may be susceptible to cracking or breaking or leaking. This could cause product leakage or, less likely, patient injury.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action The recalling firm issued an Urgent Medical Device Field Correction on 5/24/10 requesting customers to check their inventory for the affected lots and complete the fax back form with the amount of product in stock. The manufacturer plans to make arrangements to provide individually packaged low-pressure connector tubing to use with the product in the event that cracking or breaking and leaking of the T connector is observed. This requires vigilance by the customers over the life of all of the devices. For questions concerning this recall, please contact the company 1-800-633-7231, select option 2, and indicate that you are calling about the Stellant CT Dual Syringe Kit field correction.
Quantity in Commerce 1,382,889 kits
Distribution nationwide and Worldwide distribution includes AU, BE, BG, BM, BR, CA, CH, CI, CL, CN, CO, CS, DE, DK, EC, EG, FI, FR, GB, GT, HN, IN, IT, JM, JP, KW, KY, MU, MX, MY, NL, OM, PA, PH, PK, PR, SE, SG, TW, YE, ZA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DXT and Original Applicant = MEDRAD, INC.
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